CytomX Therapeutics Announces FDA Clearance of Investigational New Drug Application for CX-2029, a CD71-Directed Probody Ther...
22 Mayo 2018 - 6:30AM
CytomX Therapeutics, Inc. (Nasdaq:CTMX) a clinical-stage
oncology-focused biopharmaceutical company pioneering a novel class
of investigational antibody therapeutics based on its Probody™
therapeutic technology platform, today announced that the U.S. Food
and Drug Administration has cleared its Investigational New Drug
(IND) application for CX-2029, a first-in-class CD71-directed
Probody™ drug conjugate being co-developed by CytomX and its
partner AbbVie. CD71, also known as the transferrin receptor 1, is
a highly expressed protein present in a number of solid and
hematologic cancers that possess attractive molecular properties
for the efficient delivery of cytotoxic payloads to tumor cells.
The achievement of this milestone triggers a $25 million payment to
CytomX from AbbVie.
“CD71 has long been considered a high potential but challenging
target for antibody drug conjugates given its high expression in
tumors but ubiquitous expression in normal tissues. However, we see
CD71 is an attractive candidate for a Probody drug conjugate
approach, since our technology can potentially localize treatment
directly to tumor tissue,” said Sean McCarthy, D.Phil., president
and chief executive officer of CytomX Therapeutics. “With CX-2029
now clear to advance into Phase 1, CytomX and our partners now have
four clinical-stage Probody programs with anticipated initial data
readouts later this year from our two wholly-owned programs, CX-072
and CX-2009. It is also noteworthy that this milestone comes just
two years following the signing of our agreements with AbbVie,
reflecting the efficiency of this collaboration.”
“The IND clearance of CX-2029 marks an important step in our
partnership with CytomX,” said Steve Davidsen, Ph.D., vice
president, oncology drug discovery, AbbVie. “Our partnership has
the potential to advance emerging areas of science with the hope of
providing additional options for people living with cancer.”
About the CollaborationAbbVie and CytomX are
co-developing CX-2029, a Probody drug conjugate against CD71, with
CytomX leading pre-clinical and early clinical development. AbbVie
will lead later development and commercialization, with global
late-stage development costs shared between the two companies.
CytomX is eligible to receive up to $470 million in
development, regulatory and commercial milestones, pending the
achievement of pre-determined outcomes. AbbVie will lead
global commercial activities with CytomX eligible to receive a
profit share in the U.S. and tiered double-digit royalties on net
product sales outside of the U.S. CytomX retains an option to
co-promote in the U.S.
AbbVie also received exclusive worldwide rights to develop and
commercialize Probody drug conjugates against up to two additional,
undisclosed targets. Should AbbVie ultimately pursue these
targets, CytomX is eligible to receive additional milestone and
royalty payments per target on any resulting products.
About CytomX Therapeutics CytomX
Therapeutics is a clinical-stage oncology-focused
biopharmaceutical company pioneering a novel class of
investigational antibody therapeutics based on its Probody
therapeutic technology platform. Probody therapeutics are designed
to exploit unique conditions of the tumor microenvironment to more
effectively localize antibody binding and activity while limiting
activity in healthy tissues. The Company’s pipeline includes cancer
immunotherapies against clinically-validated potential targets,
such as CX-072, a PD-L1-targeting Probody therapeutic wholly-owned
by CytomX, BMS-986249, a CTLA-4-targeting Probody therapeutic
partnered with Bristol Myers Squibb, CX-188, a PD-1-targeting
Probody therapeutic wholly-owned by CytomX, and first-in-class
Probody drug conjugates against high potential targets, such as
CX-2009, a CD166-targeting Probody drug conjugate wholly-owned by
CytomX and CX-2029, a CD71-targeting Probody drug conjugate
partnered with AbbVie, which are considered to be inaccessible to
conventional antibody drug conjugates due to their presence on
healthy tissue. In addition to its wholly owned programs, CytomX
has strategic collaborations with AbbVie, Amgen, Bristol-Myers
Squibb Company, and ImmunoGen, Inc. For more information, visit
www.cytomx.com or follow us on Twitter.
CytomX Therapeutics Forward-Looking Statements
This press release includes forward-looking statements. Such
forward-looking statements involve known and unknown risks,
uncertainties and other important factors that are difficult to
predict, may be beyond our control, and may cause the actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied in such statements. Accordingly, you should not rely on any
of these forward-looking statements, including those relating to
the potential efficacy of CX-2029, the Company’s ability to develop
and advance CX-2029 into and successfully complete clinical trials,
and the timing of any future clinical trials of CX-2029. The
process by which preclinical and clinical development could
potentially lead to an approved product is long and subject to
significant risks and uncertainties. Collaborations with partners
may not result in products, and milestone payments and royalties
may not be received. Applicable risks and uncertainties include
those relating to our preclinical research and development,
clinical development, collaborations and other risks identified
under the heading "Risk Factors" included in the Company’s Annual
Report on Form 10-K filed with the SEC on May 9,
2018. The forward-looking statements contained in this press
release are based on information currently available to CytomX and
speak only as of the date on which they are made. CytomX does not
undertake and specifically disclaims any obligation to update any
forward-looking statements, whether as a result of any new
information, future events, changed circumstances or otherwise.
CytomX TherapeuticsInvestors: Christopher
Keenan VP, Investor Relations and Corporate
Communicationsckeenan@cytomx.com650-383-0823
Media:Spectrum Christine Querncquern@spectrumscience.com
202-587-2588
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